From 2008 through 2017, we helped clients earn 117 new drug application (NDA) approvals. That’s twice as many as any other CMO/CDMO. Partner with Thermo Fisher Scientific and benefit from our depth and breadth of experience, reliability of quality and refinement of processes—are all of which are vital in the final push for regulatory approval and in making the transition to commercial manufacturing.
With industry-leading depth of expertise and resources, responsiveness, flexibility, and dependable quality, Thermo Fisher Scientific teams understand the approval process inside and out. We can work with you to achieve parallel active pharmaceutical ingredient (API) and finished dose development—bringing Right First Time/On-time reliability. Our seasoned experts know exactly what’s required and the pitfalls that lead to costly delays. We consistently deliver high quality in everything we do, and this has earned us the trust of the world’s top 20 pharmaceutical companies, and 18 of the top 20 biotech companies.
Where some may view regulatory inspections as a hurdle, we view them as an impartial measure of excellence. In the past 10 years, our facilities have undergone more than 325 regulatory inspections and 33 pre-approval inspections (PAIs) have been waived by the FDA. We have consistently delivered this level of quality for clients year after year, for more than 10 years.
Last year alone, we manufactured more than 700 large and small molecule products, approved for more than 70 countries. But success isn’t just about scale, it also reflects our ability to deliver exceptional quality and service. In 2008, 2010, 2011 and 2012 we were recognized with the European Outsourcing Award for Most Effective Scale-up and Technology Transfer. Source: PharmSource® Trend Report, March, 2016.
Looking for a partner for a commercial pharmaceutical manufacturing project?